Valproic Acid (Depakote ER) in Patients With Advanced Thyroid Cancer

Recruitment Status
TERMINATED - HAS RESULTS
(See Contacts and Locations)Verified December 2014 by University of California, San Francisco
Sponsor
University of California, San Francisco
Information Provided by (Responsible Party)
University of California, San Francisco
Clinicaltrials.gov Identifier
NCT00525135
Other Study ID Numbers:
Valproic Acid
First Submitted
August 27, 2007
First Posted
September 4, 2007
Results First Posted
January 20, 2015
Last Update Posted
February 2, 2015
Last Verified
December 2014

ClinicalTrials.gov processed this data on January 2015. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

PURPOSE: This phase II trial is studying how well valproic acid works in treating patients with thyroid cancers that do not respond well to other treatments.

Condition or DiseaseIntervention/Treatment
Head and Neck Cancer
Drug: Valproic AcidDrug: Valproic Acid

Study Design

Study TypeInterventional
Actual Enrollment5 participants
Design AllocationNon-Randomized
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase II Trial of Valproic Acid (Depakote ER ®) in Patients With Advanced Thyroid Cancers of Follicular Origin, Who Are Thyroglobulin Positive/RAI Unresponsive
Study Start DateJuly 31, 2007
Actual Primary Completion DateFebruary 28, 2009
Actual Study Completion DateFebruary 28, 2009

Groups and Cohorts

Group/CohortIntervention/Treatment
1
If a patient exhibits increased radioiodine uptake on the Thyrogen scan post valproic acid therapy, patients will then prepare for ablative treatment and will remain on valproic acid for a total of 16 weeks, until receiving RAI ablation.
Drug: Valproic Acid
OUTLINE: This is a pilot study. Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment. Quality of life is assessed at the end of every week through a study diary. Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.
2
If no increased uptake is seen, patients will continue on valproic acid for 6 additional weeks at an increased dosage, totaling an overall treatment time of 16 weeks as well.
Drug: Valproic Acid
OUTLINE: This is a pilot study. Patients receive valproic acid daily for 16 weeks. Dose increases on Days 4 and 8; dose remains the same for weeks 2-10. All patients will undergo a Thyrogen® (thyrotropin alfa for injection) RAI scan at entry to the study and after completion of 10 weeks of valproic acid treatment. Quality of life is assessed at the end of every week through a study diary. Patients are followed at 1, 2, 4, 6, 8, 10, 12, 14, 16, and 17 (Schedule 1) weeks. Patients return for follow-up at 3, 6, and 12 months.

Outcome Measures

Primary Outcome Measures
  1. Decrease in Thyroglobulin Level
    Number of participants with decreased thyroglobulin level after study treatment
  2. Decrease in Tumor Size
    Number of participants with decreased tumor size after study treatment
Secondary Outcome Measures
  1. Increased Radioactive Iodine Uptake
    Number of participants with increased radioiodine uptake on the Thyrogen scan post valproic acid therapy
  2. Side Effects of Drugs Affecting Quality of Life
    Number of participants experiencing \> Grade 1 adverse events (including fatigue) attributable to study treatment
  3. Survival

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
INCLUSION CRITERIA: DISEASE CHARACTERISTICS
Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive
Cumulative dose of radioiodine \< 800 mCi
No radioiodine uptake on whole body scan within 18 months of enrollment
Inoperable extensive locoregional tumor mass and/or metastatic spread
Failed conventional therapy that included total thyroidectomy AND radioactive iodine I 131 ablation
Elevated thyroglobulin level (\>2ng/ml on thyroid hormone, \>10ng/ml off thyroid hormone)or Tg-antibody positive PATIENT CHARACTERISTICS -18 years or older Entry lab results:
Hemoglobin \> 8.0 gm/dl
Absolute Neutrophil Count \> 750 cells/mm3
Platelet count \> 75000/mm3
BUN \< 1.5 times upper limit of normal (ULN)
Creatinine \< 1.5 times ULN
Total protein \> 6.4
Total bilirubin should be \< 1.5 times ULN.
AST (SGOT), ALT (SGPT), ALKP and amylase \< 1.5 times ULN
Amylase \< 1.5 times ULN
Albumin \> 2.5
Ammonia \< 1.5 times ULN EXCLUSION CRITERIA:
Not pregnant
No nursing within the past 3 months
No allergy to valproic acid
No coexisting malignancy other than basal cell carcinoma
No hepatic disease or significant dysfunction
Karnofsky score \> 80
No pancreatitis
No kidney dysfunction
Fertile patients must use effective contraception
Exclusion Criteria
INCLUSION CRITERIA: DISEASE CHARACTERISTICS
Diagnosis of advanced/poorly differentiated thyroid cancer of follicular cell origin that is radioiodine-unresponsive
Cumulative dose of radioiodine \< 800 mCi
No radioiodine uptake on whole body scan within 18 months of enrollment
Inoperable extensive locoregional tumor mass and/or metastatic spread
Failed conventional therapy that included total thyroidectomy AND radioactive iodine I 131 ablation
Elevated thyroglobulin level (\>2ng/ml on thyroid hormone, \>10ng/ml off thyroid hormone)or Tg-antibody positive PATIENT CHARACTERISTICS -18 years or older Entry lab results:
Hemoglobin \> 8.0 gm/dl
Absolute Neutrophil Count \> 750 cells/mm3
Platelet count \> 75000/mm3
BUN \< 1.5 times upper limit of normal (ULN)
Creatinine \< 1.5 times ULN
Total protein \> 6.4
Total bilirubin should be \< 1.5 times ULN.
AST (SGOT), ALT (SGPT), ALKP and amylase \< 1.5 times ULN
Amylase \< 1.5 times ULN
Albumin \> 2.5
Ammonia \< 1.5 times ULN EXCLUSION CRITERIA:
Not pregnant
No nursing within the past 3 months
No allergy to valproic acid
No coexisting malignancy other than basal cell carcinoma
No hepatic disease or significant dysfunction
Karnofsky score \> 80
No pancreatitis
No kidney dysfunction
Fertile patients must use effective contraception

Contacts and Locations

Sponsors and CollaboratorsUniversity of California, San Francisco
Locations
UCSF Comprehensive Cancer Center | San Francisco California, United States, 94115
Investigators
Principal Investigator: Electron Kebebew, MD, University of California, San Francisco